Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Danyang Huayi Medical Supply & Equipment Co, Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091482 | HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 2009-07-06 | 48 | 0 |
| K080207 | DANYANG HUAYI K2 AND K7 WHEELCHAIRS | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 2008-03-12 | 44 | 0 |
| K080114 | HUAYI H035 BASIC WHEELCHAIR | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 2008-02-15 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda